BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    RUBELLA IGG

    K Number: K902793 · Decision Jul 31, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    93
    Applicant Total
    7
    Review Days
    35

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    Basic Information

    Device Name
    RUBELLA IGG
    K Number
    K902793
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3510
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Pharmacia Diagnostics, Inc.
    Date Received
    June 26, 1990
    Decision Date
    July 31, 1990
    Product Code
    LFX
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LFX Enzyme Linked Immunoabsorbent Assay, Rubella

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    Other Clearances by Pharmacia Diagnostics, Inc.

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    K902792 TOXOPLASMA GONDII IGG